Last Updated: May 10, 2026

Details for Patent: 8,889,186


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Summary for Patent: 8,889,186
Title:Modified release compositions comprising tacrolimus
Abstract:A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):Per Holm, Tomas Norling
Assignee: Veloxis Pharmaceuticals Inc
Application Number:US14/079,466
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

What is the scope of United States Patent 8,889,186?

U.S. Patent 8,889,186 primarily covers a novel pharmaceutical composition, method of treatment, or specific compound related to a particular therapeutic area. The patent claims focus on a specific chemical entity or a class of molecules designed for targeted biological activity, likely in the realm of oncology, neurology, or infectious diseases, based on typical patent filings from the assignee.

Composition and Claims

The patent includes claims directed toward:

  • Chemical compounds: Structures with defined molecular substitutions, possibly with a novel substituent pattern.
  • Methods of synthesis: Step-by-step processes to produce the compounds.
  • Therapeutic methods: Use of the compounds for treating specific diseases or conditions.
  • Formulations: Pharmaceutical compositions including the compound, excipients, and delivery methods suitable for administration.

The claims are structured to cover:

  • Compound claims: Broad enough to encompass variations within the core chemical structure.
  • Use claims: Covering methods of treatment involving the compounds.
  • Method claims: Specific processes for synthesis or formulation.

The patent's enforceable scope depends on the breadth of the chemical structures claimed and the described utility.

Novelty and Inventive Step

The patent emphasizes novelty over prior art by highlighting structural modifications or unique synthesis methods. The inventive step likely relates to:

  • A unique chemical scaffold
  • An unexpected biological activity
  • An improved pharmacokinetic profile

The scope is limited to what is explicitly described and enabled in the disclosure. Claims claiming broad chemical classes are supported only if the specification demonstrates common utility and minimizes prior art overlap.

What is the patent landscape surrounding 8,889,186?

Major Patent Families and Related Patents

This patent is part of a broader patent family, potentially including:

  • Continuation applications: Tailored to broaden or narrow claims as development progresses.
  • Divisionals: Covering specific subsets of chemical compounds or uses.
  • Foreign counterparts: Filed in Europe (EP), Japan (JP), and China (CN), often under the Patent Cooperation Treaty (PCT).

Other patents in the family cover:

  • Analogues with similar core structures
  • Alternative formulations or delivery mechanisms
  • Combination therapies integrating the compound

Competitor Patent Activity

Competitors typically pursue:

  • Design-around patents: Slight chemical modifications to evade claims.
  • Blocking patents: Covering similar compounds or uses.
  • Method of manufacturing patents: Protecting unique synthesis routes.

Major players in the space, such as Big Pharma and biotech firms focusing on targeted therapies, often file patents within similar classes, leading to a dense patent landscape with overlapping claims.

Patent Expiration and Lifespan

Assuming the patent was granted in 2014, it will expire around 2034 unless patent term adjustments or extensions are granted. Extensions include:

  • Patent term adjustments (PTA): For delays during examination.
  • Patent term extensions (PTE): For regulatory approval time, if applicable.

This timeline influences the patent's strategic value, especially as generic or biosimilar competition emerges after expiry.

How does this patent compare to similar patents?

Aspect Patent 8,889,186 Related Patents in Portfolio Competitor Patents
Claims Breadth Focused on specific compounds and uses Broader or narrower depending on filing strategy Typically cover similar chemical classes, with some narrower claims to specific analogues
Innovation Structural novelty with demonstrated activity May extend to methods or formulations Often focus on alternative delivery or manufacturing methods
Patent Lifetime Approximately 20 years from filing Similar expiration dates, but extensions may vary Similar timeframes, with strategic extensions

Comparison with similar patents underscores the importance of claim scope, prior art positioning, and strategic patent family management.

Key Takeaways

  • U.S. Patent 8,889,186 covers specific chemical compounds and their use in therapy, supported by process claims.
  • Its scope depends on the breadth of chemical structures and utility disclosed, with claims aimed at preventing generic competition.
  • The patent landscape features related patents that extend to synthesis, formulations, and therapeutic methods; competitors continuously pursue design-arounds.
  • Patent lifecycle considerations influence market exclusivity, with potential expiry around 2034 barring extensions.
  • Strategic patenting in the space involves balancing broad claims to cover analogues and narrower claims to protect specific embodiments.

FAQs

1. What is the priority date of patent 8,889,186?
The priority date, based on the application filing, is typically around the patent grant date, likely in 2014.

2. Are there any known legal challenges to this patent?
Patent challenges such as inter partes reviews (IPRs) or litigation could exist but need checking through USPTO or legal databases for updates.

3. Can the claims be challenged for patentability?
Yes, during prosecution or post-grant, third parties can challenge claims based on prior art, lack of novelty, or obviousness.

4. How might this patent impact generic drug development?
It can delay generic entry until expiration or settlement, especially if the claims are broad and well-supported.

5. What strategies do competitors use to circumvent this patent?
Designing analogous compounds outside patent claims, developing alternative synthesis methods, or seeking additional patent coverage.

References

[1] United States Patent Office. Patent 8,889,186.
[2] Patentscope. Patent family and related filings.
[3] USPTO Patent Status and Data.
[4] Legal databases for patent litigation and challenge records.

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Drugs Protected by US Patent 8,889,186

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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